BioMelbourne Network
Progressing BioIndustry
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11th May - BioBreakfast:
The Development of Biosimilars
The fall-out from the US healthcare reform decision Event Description
| When: |
Tuesday 11th May 2010 Registration 7.15am Buffet Breakfast 7.20 - 7.55am Presentation 8am sharp Concludes at 9am |
|---|---|
| Where: |
The Supper Room Melbourne Town Hall |
| Speakers: |
Ms Leah Taylor (Vice President - Intellectual Property, Hospira) |
| Price: |
BioMelbourne Network members: $55.00 Non members: $88.00 Prices include GST |
| RSVP: | Friday 7th May, 12pm |
About This Event
On 21 March 2010, the US House of Representatives passed one of the largest healthcare reform bills seen in the last 40 years. Included in this bill was the provision that gives the US FDA the authority to approve biosimilar versions of biological drugs (biologics) for the first time. The legislation also contained one of the most contentious issues for the biopharmaceutical industry, a 12 year period of exclusivity for data relating to new biologics. In other words, no application for any biosimilar product can be approved prior to the date that is 12 years after the original (reference) product was first licensed. Assuming that a biologic is approved, this new 12 year period of data exclusivity provides biotechnology companies with the possibility of extending the protection of the biologic beyond the lifetime of the patent. This decision has been both welcomed and derided by the biopharmaceutical industry. It rewards the brand companies for years of research and massive investment in the discovery and development of biologics however generic pharmaceutical companies claim that it gives excessive and unprecedented exclusivity protections to brand pharma companies. They claim the problems of “evergreening” and extended brand biologic monopolies still remain.
At the May 11th BioBreakfast, Ms Leah Taylor (VP Intellectual Property, Hospira) will outline Hospira’s position. She will discuss the balance between access and innovation and what the decision will mean for the cost of biologics for the end consumer.
The legislation also raises a number of questions. Will it stifle research and development of biosimilars for biologics? Will it mean that more patients will be unable to afford access to life-saving drugs? Is Australia likely to follow the US based on the principle of the US free-trade agreement?
And the ultimate question has the US got the balance right?
About the Speakers
Leah Taylor, B.Sc. LLB (Hons.), Registered Patent Attorney (Australian Prize Winner 1996), Vice President, Intellectual Property (IP), Hospira Pty Ltd
Leah is a member of the Hospira legal team and has been with Hospira since its acquisition of Mayne Pharma Ltd in 2007. From 2001 to 2007, Leah worked at Mayne Pharma Ltd & FH Faulding & Co Ltd.
Currently Leah is head of the Hospira Pharma IP group which handles all pharma patent work for the Hospira group of companies including global litigation, oppositions, IP strategy development, global lobbying, and patent filing and prosecution.
Leah’s team are located in the US, UK & Australia.
Leah qualified as a lawyer in 1993 and prior to 2001 worked in Australian law firms, namely Allens Arthur Robinson, McMaster & Associates, and Freehills.
Event Location
The Supper Room
Melbourne Town Hall
Cnr Swanston and Collins Sts
Melbourne
